Application 017463
- Type
- NDA
- Sponsor
- MCNEIL CONSUMER
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | MOTRIN | IBUPROFEN | TABLET;ORAL | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | MOTRIN | IBUPROFEN | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | MOTRIN | IBUPROFEN | TABLET;ORAL | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | MOTRIN | IBUPROFEN | TABLET;ORAL | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017463-002 | MOTRIN | IBUPROFEN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017463-003 | MOTRIN | IBUPROFEN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017463-004 | MOTRIN | IBUPROFEN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N017463-005 | MOTRIN | IBUPROFEN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017463-002 | MOTRIN | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017463-003 | MOTRIN | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017463-004 | MOTRIN | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017463-005 | MOTRIN | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-05-22 | 5bbf6a4d5a75… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ibuprofen | IBUPROFEN | RETAIL BUSINESS SERVICES , LLC. | 8f9f099a-ee59-0b9a-e053-2a95a90a2fe1 | 2025-11-18 | Warnings | IBUPROFEN |
| IBUPROFEN | IBUPROFEN | RETAIL BUSINESS SERVICES , LLC. | 8f9f40f5-625d-3f2e-e053-2a95a90a438b | 2025-11-18 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | RETAIL BUSINESS SERVICES , LLC. | 8f9f42a7-c2d8-4a51-e053-2a95a90a1677 | 2025-11-18 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | RETAIL BUSINESS SERVICES , LLC. | 8f9f308f-0ca5-12fa-e053-2995a90a47fc | 2025-11-18 | Warnings | IBUPROFEN |
| MOTRIN IB | IBUPROFEN | R J General Corporation | afa87bb5-7fcb-4ccd-acac-f7931242181f | 2025-11-17 | Warnings | IBUPROFEN |
| Ibuprofen 200 mg | IBUPROFEN | R J General Corporation | dd9aaf80-6c2b-41a3-87b9-61642aaed4f0 | 2025-11-17 | Warnings | IBUPROFEN |
| Ibuprofen 200 mg | IBUPROFEN | R J General Corporation | 1c18a2da-1718-4c00-aea8-9fb4a3418312 | 2025-11-17 | Warnings | IBUPROFEN |
| Ibuprofen 200 mg | IBUPROFEN | R J General Corporation | cd3060a5-3b90-42e4-89cd-3b620859045f | 2025-11-17 | Warnings | IBUPROFEN |
| Ibuprofen 200 mg | IBUPROFEN | R J General Corporation | 1c7221ae-52d1-4d18-b586-c47ff656150d | 2025-11-17 | Warnings | IBUPROFEN |
| good sense ibuprofen | IBUPROFEN | Preferred Pharmaceuticals Inc. | c447fc6b-e9ef-447a-9609-5f893e18dfa7 | 2025-11-17 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Family Dollar Services Inc | 89ed9311-2185-4660-b219-9ea67b1a71ec | 2025-11-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Topco Associates, LLC | bcf7d4c1-1f99-48df-8f74-9abeefa8d41d | 2025-11-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | L.N.K. International, Inc. | d1f20e10-0128-f2e5-1a03-6da5d7288a4e | 2025-11-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | ARMY AND AIR FORCE EXCHANGE SERVICE | bf7d0929-a7d5-4164-9c24-566eddcd6489 | 2025-11-15 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | P & L Development, LLC | ce215099-91b0-43fd-8ac9-17fe6508842c | 2025-11-11 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | da9d0301-ec14-40c5-b0b9-17096913a849 | 2025-11-11 | Warnings | IBUPROFEN |
| GOODNOW PAIN RELIEF | IBUPROFEN | Gobrands, Inc | 0759085d-6ac3-446b-ac2c-8dc30e32e1d1 | 2025-11-08 | Warnings | IBUPROFEN |
| childrens ibuprofen | IBUPROFEN | Kroger Company | 96c955b1-3139-4b12-b584-83804bc1ca6b | 2025-11-03 | Warnings | IBUPROFEN |
| Ibuprofen | IBUPROFEN | NuCare Pharmaceuticals,Inc. | f60445d3-807e-0bbf-e053-2995a90a1299 | 2025-10-30 | Boxed warning, Warnings, Adverse reactions | IBUPROFEN |
| KOSHER MEDS | IBUPROFEN | Mollec Inc | c9c31326-6a19-9a9c-e053-2a95a90aed06 | 2025-10-29 | Warnings | IBUPROFEN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.